Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women
NCT ID: NCT03416010
Last Updated: 2025-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2018-03-05
2023-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Control
In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention
No interventions assigned to this group
Intervention
In addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team.
COPE-P
Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave).
Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones.
Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses.
Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication.
Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.
Interventions
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COPE-P
Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave).
Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones.
Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses.
Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication.
Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.
Eligibility Criteria
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Inclusion Criteria
* Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
* Self-identified as either Black or Hispanic
* Able to read and speak English.
* The child participants born to the participants will have their record accessed for data collection.
Exclusion Criteria
* Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.
18 Years
40 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
New York University
OTHER
Jacobi Medical Center
OTHER
Boston College
OTHER
University of Arizona
OTHER
Drexel University
OTHER
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of South Florida
OTHER
Ohio State University
OTHER
Responsible Party
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Bernadette Melnyk
Dean and Professor, College of Nursing Vice President of Health Promotion, Professor of Pediatrics and Psychiatry, College of Medicine
Principal Investigators
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Bernadette Melnyk, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Jacobi Medical Center
The Bronx, New York, United States
OSU Total Health and Wellness
Columbus, Ohio, United States
OSUWMC OB/GYN Clinic
Columbus, Ohio, United States
Countries
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References
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Gennaro S, Melnyk BM, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper AR, Aviles MM. Effects of Two Group Prenatal Care Interventions on Mental Health: An RCT. Am J Prev Med. 2024 May;66(5):797-808. doi: 10.1016/j.amepre.2024.01.005. Epub 2024 Feb 5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Ohio Study Protocol
Document Type: Study Protocol and Statistical Analysis Plan: New York Study Protocol
Document Type: Informed Consent Form: Ohio Informed Consent Form
Document Type: Informed Consent Form: New York Informed Consent Form
Other Identifiers
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2017B0425
Identifier Type: -
Identifier Source: org_study_id
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